Trial of Curcumin to Prevent Progression of Low-risk Prostate Cancer Under Active Surveillance
About this study
This is a prospective study to determine if the use of curcumin randomized against placebo will reduce cancer progression in patients with prostate cancer undergoing active surveillance.
- Condition
- Prostate Cancer
- Tested
- Curcumin, Placebo
- Sponsor
- University of Texas Southwestern Medical Center
Who can join
- Age
- 40 to 89 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
Inclusion 12
- Minimum age: 40 years
- Maximum age: 89 years
- Eligible sex: Male
- Study condition: Prostate Cancer
- Age between 40-89 years
- Biopsy proven, low-risk, localized prostate cancer (minimum of 8 cores)
- May have had biopsy within last 12 months
- ≤4 separate locations in the prostate involved with cancer. If multiple cores are obtained from same lesion or area than this will count as one location.
- Gleason score ≤6 with no Gleason pattern 4
- Clinical stage T1c-T2a/b
- Serum PSA ≤15 ng/ml
- Life expectancy \> 5 years
Exclusion 8
- Any previous prostate cancer treatment (radiotherapy, chemotherapy, hormonal therapy, oral glucocorticoids, GnRH analogues, prostatectomy)
- Concurrent or previous use within 6 months of screening of any 5α-reductase inhibitor
- Use of anabolic steroids or drugs with antiandrogenic properties
- Prostate volume \>150 cm³
- Patients who are taking antiplatelet, anticoagulant agents or have a history of a bleeding disorder. Patients taking 81 mg of Aspirin will be allowed to enroll with close observation
- History of gastric or duodenal ulcers or untreated hyperacidity syndromes. Patients on stable doses (2 months of therapy) of GERD medication allowed.
- Patients who are currently taking Curcumin and are unwilling to stop or plan to take Curcumin during the study
- Patients with a history of gallbladder problems or gallstones or biliary obstruction, unless patient had cholecystectomy
Where
1 site, 1 recruiting
UT Southwestern Medical Center
Dallas, Texas, United States
Contact
-
Catherine Robinson
214-645-8103 Catherine.Robinson@utsouthwestern.edu
-
Maricruz Ibarra
214-645-8788 maricruz.ibarra@utsouthwestern.edu
Potential match only. Final eligibility is determined by the study team.